Allergy Relief
- Product NDC
- 61504-194
- 11-digit product format
- 615040194
- Labeler code
- 61504
- Product ID
- 61504-194_092d4666-dc93-1c0f-e063-6294a90a7aaf
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Amerifoods Trading Company
- Application
- ANDA209274
- Marketing category
- ANDA
- Marketing start
- 2023-10-30
- Substance
- CETIRIZINE HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2017-12-22 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 3a93d1ddd44b… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Allergy Relief
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CETIRIZINE HYDROCHLORIDE | 10 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 64O047KTOA | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1014678 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f6ce3cdf-2e6d-61e8-e053-6294a90af7d3 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be | Product name | 1 | 20200304 |
| a255659f-db40-429d-8c07-5f173f330d9c | Product name | 1 | 20190402 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61504-194-14 | Allergy Relief | 30 in 1 BOTTLE, PLASTIC | TABLET, COATED | 30 | 2 | |
| 61504-194-14 | Allergy Relief | 1 in 1 CARTON | TABLET, COATED | 1 | 2 | |
| 61504-194-16 | Allergy Relief | 90 in 1 BOTTLE, PLASTIC | TABLET, COATED | 90 | 2 | |
| 61504-194-16 | Allergy Relief | 1 in 1 CARTON | TABLET, COATED | 1 | 2 |
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Cetirizine hydrochloride | CETIRIZINE HYDROCHLORIDE | A-S Medication Solutions | f4da9adf-840d-4526-86a6-6666183fd107 | 2023-07-06 | Warnings | 209274 ANDA209274 |
| Allergy Relief | CETIRIZINE HYDROCHLORIDE | United Natural Foods, Inc. dba UNFI | adcd0e8e-cca7-e1bb-e053-2995a90a83be | 2023-05-17 | Warnings | 209274 ANDA209274 |
| Crcle Cetirizine Hydrochloride | CETIRIZINE HYDROCHLORIDE | Innovus Pharmaceuticals, Inc. | 640583b6-379d-4ad3-b00c-383377c54eed | 2023-04-21 | Warnings | 209274 ANDA209274 |
| Allergy Relief | CETIRIZINE HYDROCHLORIDE | WINCO FOODS, LLC | f45f5920-d82f-6549-e053-2995a90ad58a | 2023-04-11 | Warnings | 209274 ANDA209274 |
| Allergy Relief | CETIRIZINE HCL | CVS PHARMACY, INC | 34c9e7b3-ccba-4f22-a4d3-20724e7de486 | 2023-02-17 | Warnings | 209274 ANDA209274 |
| Allergy Relief | CETIRIZINE HYDROCHLORIDE | MARC GLASSMAN, INC. | 951b6f19-15fe-45d7-e053-2995a90aa254 | 2022-10-06 | Warnings | 209274 ANDA209274 |
| Allergy Relief | CETIRIZINE HCL | WinCo Foods, LLC | 39a7d993-805d-4fe8-bc21-3b08e8f78b62 | 2022-05-11 | Warnings | 209274 ANDA209274 |
| Allergy Relief | CETIRIZINE HYDROCHLORIDE | Magno-Humphries, Inc. | f0a3e654-5fec-4f98-84da-4c30500633b4 | 2021-10-28 | Warnings | 209274 ANDA209274 |
| ALLERGY RELIEF | CETIRIZINE HYDROCHLORIDE | RETAIL BUSINESS SERVICES , LLC. | 95bf367c-eea8-73f9-e053-2a95a90a3dea | 2021-07-12 | Warnings | 209274 ANDA209274 |
| Cetirizine hydrochloride | CETIRIZINE HYDROCHLORIDE | Strive Pharmaceuticals Inc | a4ebeec7-0245-4f77-e053-2995a90a7e7f | 2020-11-17 | Warnings | 209274 ANDA209274 |
| ALLERGY RELIEF | CETIRIZINE HYDROCHLORIDE | DISCOUNT DRUG MART | 844e0e60-f293-4588-9f34-c866bdad6f53 | 2020-09-11 | Warnings | 209274 ANDA209274 |
| Allergy Relief | CETIRIZINE HCL 10 MG | Allegiant Health | bef9e980-37b4-430d-8635-3354d578b3b8 | 2019-12-12 | Warnings | 209274 ANDA209274 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1014678 | cetirizine HCl 10 MG Oral Tablet | PSN | f6ce3cdf-2e6d-61e8-e053-6294a90af7d3 | 2 |
| 1014678 | cetirizine hydrochloride 10 MG Oral Tablet | SCD | f6ce3cdf-2e6d-61e8-e053-6294a90af7d3 | 2 |
| 1014678 | cetirizine HCl 10 MG Oral Tablet | SY | f6ce3cdf-2e6d-61e8-e053-6294a90af7d3 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 61504-194-14 | 61504019414 | 1 BOTTLE, PLASTIC in 1 CARTON (61504-194-14) / 30 TABLET, COATED in 1 BOTTLE, PLASTIC | 2023-10-30 | No | No | Current |
| 61504-194-16 | 61504019416 | 1 BOTTLE, PLASTIC in 1 CARTON (61504-194-16) / 90 TABLET, COATED in 1 BOTTLE, PLASTIC | 2023-10-30 | No | No | Current |